Audit Trail Reviews for Data Integrity

Audit trail is a record of the “who, what, when, and why” of a record. Data integrity arrangements must ensure that the accuracy, completeness, content and meaning of data is retained throughout the data lifecycle. Electronic audit trails include those that “track creation, modification, or deletion of data”.  The FDA recommends routine scheduled audit trail review based on the complexity of the system and its intended use. A review should include data and meaningful metadata.


FDA Guidelines

The FDA’s 2016 Guidance on Data Integrity states the following:  Audit trails are considered part of the associated records.  Personnel responsible for record review under cGMP should review the audit trails that capture changes to critical data associated with the record as they review the rest of the record. For example, all production and control records, which includes audit trails, must be reviewed and approved by the quality unit.  This is similar to the expectation that cross-outs on paper be assessed when reviewing data.  The guidance also recommends routine scheduled audit trail review commensurate to cGMP risk.  Personnel reviewing audit trails should be trained to detect data integrity issues.

How does your Company’s systems stack up to this FDA Guideline?

Is your Data subject to audit trails identified in the User Requirement Specification?

Are your Personnel reviewing the audit trails trained to detect integrity issues?

Is your audit trail review part of the routine data review/approval process?

Do you perform periodic review of active users in the system?

Does your audit trail contain the following minimal information:

  • Person making the change
  • Timestamp of when the change is made
  • Reason for the change or what parameters were changed if relevant
  • Value changed from (previous data value)
  • Value changed to (new data value)

Have you determined the audit trail review method and frequency?

Have you evaluated the impact of data to product quality and patient safety?

Can you provide evidence to confirm that review of the relevant audit trails has taken place?

If using a paper-based audit trail, does it comply with the Regulatory Requirements listed above?

You Need to Be Audit Ready

To be Audit ready, Dataworks can help you answer the above questions and put an Audit Trail Review Procedure in place to ensure that your systems meet regualtory requirements.

At Dataworks our highly skilled CSV & Software Engineers provide a full range of Data Integrity services as part of our validation offering including:

  • Data Integrity Assessments
  • Remediation Software
  • Validation Services

Our team of experienced engineers can help you to enable greater efficiencies, improved quality and compliancy within your industry.

If you would like to discuss how we can help you with your Data Integrity projects please Contact Us or call us today on 051 878555.

To stay up to date with Dataworks Limited news and events, connect with us via the links below: